The present invention is generally in the field of controlled drug delivery, and particularly in the area of direct delivery of anti-arrhythmic agents to the surface of the heart and its associated tissues.
Coronary artery bypass graft (CABG) surgery is a standard surgical that procedure that replaces clogged or degraded cardiac arteries. However, the act of operating on the heart can disturb the regulation of the heartbeat. Postsurgical arrhythmias resulting from this disturbance can complicate the recovery process and can be fatal.
Atrial fibrillation is the most common postsurgical arrhythmic event following open heart surgery. Postoperative atrial fibrillation has been found to occur following approximately 20–30% of all CABG and valve procedures, and usually occurs within 10 days following surgery. Anti-arrhythmic drugs typically are administered orally or by IV either to treat atrial fibrillation when it occurs or as a prophylactic therapy. However, systemic administration of anti-arrhythmic agents is not always desirable or practical.
Administration of anti-arrhythmic agents to cardiac tissue, directly or on a pacemaker lead, has been proposed in U.S. Pat. No. 5,387,419 and WO 94/21237 to Levy and Sintov. U.S. Pat. No. 5,387,419 describes the direct application of anti-arrhythmic agents in a carrier. However, this application has proven to be impractical because the carriers are not tissue adherent and do not bioresorb. For example, U.S. Pat. No. 5,387,419 describes placing lidocaine in polyurethane, which must be prepared outside the body at 60° C. and then sutured to the heart.
There is a need for more practical methods of administration of anti-arrhythmic agents.
It is therefore an object of this invention to provide controlled delivery of anti-arrhythmic drugs through the direct application of tissue adherent polymeric hydrogel matrices.